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a crucial momenT in Time for STem cell r&d
Medicine By Design - CFREF Funding Announcement
In an interview with the Edmonton Sun in April, Dr. James Shapiro sketched out a not-far-off future in which diabetics won’t need daily insulin injections.
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“We have successfully and reliably reversed diabetes in our preclinical models,” the University of Alberta researcher/clinician told his hometown paper. “This approach is new and especially exciting as it opens up a world of opportunities.”
Dr. Shapiro, who was part of the team that developed the Edmonton Protocol to treat type 1 diabetes with transplanted pancreatic islets, received Health Canada’s approval earlier this year to conduct a Phase 1/2 clinical trial of a stem cell-derived islet replacement treatment for diabetes. The therapy, which he helped develop with San Diego-based ViaCyte, Inc., involves inserting a device about half the size of a credit card and loaded with pancreatic progenitor cells under the patient’s skin, where new blood vessels grow around it and the body’s immune system doesn’t try to destroy it, enabling regulation of blood glucose levels. The Edmonton trial, supported by Alberta Innovates – Health Solutions and JDRF, follows one ViaCyte began last year in San Diego, CA.
If the device works, the impact could be transformative. According to Statistics Canada, more than 2 million Canadians have diabetes. The Canadian Diabetes Association puts the number at over 10 million when people with type 2 diabetes and those Canadians in pre-diabetes are included.
News this summer of the commencement of the Canadian trial couldn’t be timelier. For the past 17 years -- since the discovery of embryonic stem cells -- the field of regenerative medicine has been long on promise, short on product. But this is changing. In many ways, Dr. Shapiro is at the same crucial moment in time as many of Canada’s elite stem cell/regenerative medicine researchers: on the verge of delivering new treatments for a number of diseases. To note a few: • Researchers at Toronto’s University Health
Network have begun a pilot study to treat patients with knee osteoarthritis using mesenchymal stem cells. • Clinical trials are in the works using a molecule called UM171 developed by Dr. Guy
Sauvageau of the Université de Montréal to expand umbilical cord blood stem cells while maintaining their properties. (Currently, donated umbilical cords have too few cells to treat adult cancer patients.) • Dr. Duncan Stewart of the Ottawa Hospital Research Institute leads a two-year, 100-patient study in Ottawa, Montréal and
Toronto to test using genetically enhanced stem cells to rebuild heart tissue damaged by heart attacks. • Dr. Mark Freedman at the Ottawa Hospital
Research Institute co-leads a 40-patient trial with Dr. James J. Marriott of the University of Manitoba, called MESCAMS (for
MEsenchymal Stem cell therapy for CAnadian MS patients).
• Dr. Michael Fehlings of Toronto’s University Health Network leads a first-of-its kind
North American study to test using neural stem cells to treat spinal cord injury.
What’s remarkable is that Canadian labs are producing this kind of world-leading work on a shoestring, with funding resources that are diminishing. The sunsetting Stem Cell Network, which co-ordinated the efforts of stem cell researchers from St. John’s to Victoria, was able to leverage the almost $83 million in taxpayer funding it received over its 15-year run many times over. But compare that to the $3 billion that California -- with a similar population to Canada -- assigned to advance the translation of stem cell research into new therapies and you get a pretty good idea of what Canadian scientists are up against.
The federal government’s recent announcement of $114 million over seven years for the University of Toronto’s Medicine by Design project, which includes stem cell/regenerative medicine R&D, is very good news for the GTA research hub, as is the Ontario’s $25-million, five-year commitment to the Ontario Institute of Regenerative Medicine. But compare those investments to Japan’s all-in approach: $1 billion to turn induced pluripotent stem (iPS) cells discovered by Nobel Prize-winner Shinya Yamanaka into treatments. Japan also revamped its legislation to make it a magnet for clinical trials.
“I want us, Japan, to dominate the world in the area of therapies using iPS cells,” Dr. Masayo Takahashi, who leads a macular degeneration study now underway at the government-funded Riken research centre, told Bloomberg News. “It feels like the government is opening one door after another to help.”
Meanwhile Canada, the country where stem cells were discovered by Drs. James Till and Ernest McCulloch in the early 1960s, has no comprehensive strategy in place for moving stem cells out of the lab and into the clinic.
“Generally, the pace (of funding) is slower and I think we are losing ground compared to other jurisdictions,” Dr. Stewart told the Ottawa Citizen in July. The article pointed out that just as the promise of potential new stem cell therapies is blossoming, research funding is more uncertain than ever. “Canada has been a leader in this area,” said Dr. Stewart. “It would be a shame if we were to slide back.”
This comes despite the Federal Government’s Advisory Panel on Healthcare Innovation citing stem cells as an important part of the solution to transforming health care. The panel, led by the University of Toronto’s former president Dr. David Naylor, found that “the inter-related areas of stem cell science, tissue engineering and regenerative medicine have opened up new therapeutic vistas.”
Many of the Advisory Panel’s suggestions resonate with sentiments contained in the Canadian Stem Cell Strategy & Action Plan, a private-sector-led plan to deliver up to 10 new curative therapies within 10 years by aligning key players in the field – including researchers, clinicians, health charities, industry leaders and philanthropists. The Action Plan was developed over 18 months of cross-Canada consultations and comes endorsed by an international panel of experts headed by Harvard Medical School’s Dr. George Q. Daley and supported by a detailed report by KPMG.
“We need a national strategy to maintain our position as a global leader in the field that we pioneered and have pushed forward,” says James Price, president and CEO of the Canadian Stem Cell Foundation (CSCF), which is championing the Action Plan. “The upside is enormous. Beyond helping provide relief to thousands of Canadians and their families who are dealing with chronic, incur-
able diseases, the Strategy & Action Plan will transform the stem cell/regenerative medicine sector into a thriving industry that generates thousands of high-quality jobs.”
During the election campaign, the CSCF hosted a website at www.stemcellstrategy. ca for Canadians to tell their federal riding candidates and party leaders that they support the Canadian Strategy & Action Plan and urging the Government to implement it.
The notion is gaining traction with those who see a need for Canada to ease its reliance on a resource-based economy. In September, the Globe & Mail challenged economists and public policy gurus to produce 15 smart ideas “that wring as much as possible out of the old economy and help a new economy flourish.” Stem cell research was Number 10, with the article suggesting Canada could become a magnet for such research.
As for what it will cost, the Strategy calls for a $1.5 billion private/public investment over 10 years. While that may seem like a big gulp, the federal government’s share is pegged at an annual average investment of $50 million. Two-thirds of the funding will come from non-federal sources, with one firm alone, STEMCELL Technologies of Vancouver, pledging $350-million in investment over the timeframe.
It plays to Canada’s strengths. Our country is an enticing location for clinical research, with highly qualified clinicians supported by experienced research staff, cutting-edge facilities, a varied patient population and attractive R&D tax credits. And it would help ease the strain on health care. In Canada, treating incurable diseases consume 67 per cent of all direct health care costs, according to the Canadian Institute for Health Information -- a burden that is building. Stem cells offer cures, not just continuous and evermore-costly symptomatic relief.
“Ultimately, it just makes sense,” says Mr. Price. “We founded this field in Canada. We excel at it. All we need to do is pull it all together and follow through on the enormous potential.”
Joe Sornberger is the author of the University of Toronto Press book Dreams & Due Diligence: Till and McCulloch’s Stem Cell Discovery and Legacy. He works with the Canadian Stem Cell Foundation as Director of Communications Programs.
To see this story online visit www.biotechnologyfocus.ca/acrucial-moment-in-time-for-stemcell-rd/
